Fasting ENHANCE Pilot Study

NCT05732935 | Active Not Recruiting

• 3 other identifiers: IRB202202838R21AG081667PRO00048080
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Grounded in the principles of geroscience, the proposed Fasting ENHANCE study will test whether a time restricted eating (TRE) regimen can improve cognitive function and other aspects of successful aging in a safe and sustainable manner in at risk overweight older adults. Specifically, this study will evaluate whether TRE can improve cognitive and physical function, as well as self-reported sleep, mood, and quality of life, in overweight, older adults (age \> 65 years) who are at high risk of cognitive decline due to self-reported cognitive difficulties. Eligible participants will be assigned to either a TRE intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period.

Conditions

Overweight and Obesity; Time Restricted Feeding; Alzheimer Disease

Keywords

Aging; Time Restricted Eating; Overweight; Obesity; Alzheimer's Disease and Related Disorders (ADRD)

Outcome Measures

Primary Outcomes (1)

• Repeatable Battery of the Assessment of Neuropsychological Status (RBANS)

  The RBANS is a neuropsychological battery of tests that has 4 repeatable forms that can be used longitudinally to measure cognitive change. It takes 30 minutes to administer and includes measures of five cognitive domains including immediate memory, visuospatial/constructional, language, attention, and delayed memory. This test is reliable in yielding results that recognize cognitive impairment associated with neurodegenerative disease. The RBANS can be used in predicting cognitive impairment with particular emphasis on the language and immediate memory subtests.

  Baseline up to Week 24

Secondary Outcomes (11)

• Montreal Cognitive Assessment (MoCA)

  Baseline up to Week 24

• 6 Minute Walk Test

  Baseline up to Week 24

• Short Physical Performance Battery (SPPB)

  Baseline up to Week 24

• Grip Strength

  1st Day of Screening

• Pittsburgh Sleep Quality Index

  Baseline up to Week 24

Study Arms (2)

Time Restricted Eating intervention

EXPERIMENTAL

In the time restricted eating condition, participants will be instructed to fast for a target of 16 hours per day for a 24 week period.

Behavioral: Time Restricted Eating intervention

Successful Aging Comparison Group (LEARN)

ACTIVE COMPARATOR

In the LEARN group, participants will be educated on health related topics similar to that of the TRE intervention for 24 weeks.

Behavioral: Successful Aging Comparison Group (LEARN)

Interventions

Time Restricted Eating intervention BEHAVIORAL

In the TRE intervention, participants will be asked to fast for a target of 16 hours per day for a period of 24 weeks. The first few weeks will involve of a ramp up to a full 16-hour fasting period (Week 1 - fast for 12-14 hours per day, Week 2 - fast for 14-16 hours per day, Week 3 - 16 - fast for 16 hours per day). Participants will be allowed to consume calorie-free beverages, tea, black coffee, sugar-free gum, and they will be encouraged to drink plenty of water throughout the entire intervention period. Participants will be asked to record the time of first and final food/drink consumption each day. Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

Also known as: TRE intervention

Time Restricted Eating intervention

Successful Aging Comparison Group (LEARN) BEHAVIORAL

In the Successful Aging Comparison Group (LEARN), participants will attend lectures on topic relevant to healthy aging at the same frequency as the group meetings in the TRE intervention. Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

Successful Aging Comparison Group (LEARN)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years;
• Body Mass Index (BMI \> 25 kg/m2)
• Normal age-, gender-, and education-adjusted performance on TICS-M (Telephone Interview for Cognitive Status)
• Responds yes to questions 1 (memory worse), 2 (word finding difficulties) or 3 (planning/organization difficulties) on the Subjective Cognitive Decline Questionnaire
• Reports onset of cognitive difficulties in past five years
• Reports they believe they are worse than others their age OR they have talked to a clinician about it.
• Provides informed consent and willing to be randomized to either intervention group.

You may not qualify if:

• Failure to provide informed consent;
• Recent History or clinical manifestation of cardiovascular disease, diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
• Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal) as determined by study physician.
• Significant cognitive impairment, defined as a scores below the cutoff for dementia on TICS-M
• Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease);
• Terminal illness with life expectancy less than 12 months, as determined by a physician;
• Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia);
• Current use of anabolic medications (i.e., growth hormones or testosterone), antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept), anticoagulant therapies (aspirin use is permitted), or antibiotics;
• Excessive alcohol use (\>14 drinks per week);
• History of drug or alcohol abuse (i.e., more than 5 drinks/day for males or more than 4 drinks/day for females);
• Planning to permanently leave the area in the next year;
• History of pulmonary disease, pneumonitis or interstitial lung disease;
• Current smoker or less than 3 years quit;
• Creatinine clearance \< 30 ml/minute by estimated Glomerular Filtration Rate (eGFR);
• Fasting \>12 hours per day

Sponsors & Collaborators

• University of Florida: lead
• Florida Department of Health, Ed and Ethel Moore Alzheimer's Disease Research Program: collaborator

Study Sites (1)

Clinical and Translational Research Building - Institute on Aging Suite

Gainesville, Florida, 32603, United States

Location

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MeSH Terms

Conditions

Overweight; Obesity; Intermittent Fasting; Alzheimer Disease

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Stephen Anton, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to either a time restricted eating intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period. This Study will examine the effects of TRE on changes in cognitive function, as assessed by the Repeatable Battery of the Assessment of Neuropsychological Status (RBANS), examine the effects of TRE on cognitive physical function, as assessed by the six-minute walk and short physical performance battery, and examine the effects of TRE on changes in mood, sleep patterns, metabolic function, and self-reported quality of life.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 17, 2023
• Study Start: March 13, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)